2018 Common Rule (45 CFR 46)

Overview

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other federal departments and agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as the Common Rule in 1991.

The 2018 Common Rule Requirements became effective January 21, 2019, with the exception of cooperative research (single IRB review) which will not be effective until January 20, 2020.

2018 Common Rule Changes
Revised Common Rule January 21, 2019
  • Definition of Human Subjects Review
  • Continuing Review
  • Exemptions
  • Informed Consent
Single IRB of Record January 25, 2018 January 2020
  • OHRP Single IRB Policy

See updated CPHS Policies and Procedures

Related information

Revised Regulation Summary of Changes Revised UCB Documents
Applicability
45 CFR 46.101 		46.101(f) - When applicable, American Indian and Alaska Native Tribal Laws will be applied.
Definitions
45 CFR 46.102
  • 46.102(e) - Definition of Human Subjects includes identifiable biospecimens.
  • 46.102(l) - Examples of what are not considered human subject research.
  • 46.102(m) - Defines Written (or, in writing) as paper or electronic format.
Assurance
45 CFR 46.103 		The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.
Exempt Research
45 CFR 46.104 		Exempt categories 1-2 and 5 are further defined, and 6 remains the same.
1: Normal educational practices not likely to adversely impact students’ opportunity to learn.
2: Criteria iii specifies that an IRB can conduct a limited review for studies in which identifiable information is obtained/recorded.
5: New section for research conducted by Federal employees.

New categories are 3-4, and 7-8 (not used at UCB):
3: Research involving benign behavioral interventions with adult subjects, in conjunction with the collection (verbal, written, data entry, audio/visual recording) of information is permitted with prospective consent and at least one of three additional criteria are met.
4: Secondary research for which consent is not required is permitted if at least one of three additional criteria are met.

UCB-specific category, #7, is changed to #70.
IRB Review of Research
45 CFR 46.109 		46.109(a) - Exempt Research that requires limited IRB review as a condition of exemption. Limited IRB Review is performed at an IRB Expedited Subcommittee meeting by an IRB Chair or an IRB Chair-designee.
46.109(f) - Continuing review is not required when:*
  • Research eligible for expedited review.
  • Research reviewed by the Limited IRB review process.
  • Research limited to only: data analysis or accessing follow-up clinical data (performed as part of clinical care).
However, 10-year approval periods are granted at UCB for tracking purposes.

*Not applicable to FDA-regulated research, or industry-sponsored research.
Criteria for IRB Approval
45 CFR 46.111 		46.111(a)(3) & 46.111(b) - Vulnerable populations:
  • Pregnant women and handicapped/mentally disabled populations are no longer considered vulnerable.
  • Individuals with impaired decision-making capacity and economically/educational disadvantaged are considered vulnerable population.
46.111(a)(7)(i) - Include adequate provisions to protect privacy of subjects / maintain confidentiality of data. DHHS guidance forthcoming.

46.11(a)(8) Approval criteria for a limited IRB review (see above).
Cooperative Research (sIRB)
45 CFR 46.114 		The final rule mandates the use of a single IRB for multisite studies. Federal departments or agencies supporting or conducting the research can determine that the use of a single IRB is not appropriate for particular types of studies. Required for NIH funded/supported research

2020 Implementation for other Federal departments or agencies
Informed Consent
45 CFR 46.116
  • 46.116(a) - New requirement of Key Information at the beginning of the consent form.
  • 46.116(b) - One (1) new Basic element of informed consent.
  • 46.116(c) - Three (3) new Additional elements of informed consent.
  • 46.116(d) - Seven (7) elements of a Broad consent form (not used at UCB).
  • 46.116(f) - Revised criteria for a General Waiver or Alteration of Consent.
  • 46.116(g) - New exception to Informed Consent: Screening, recruiting, determining eligibility is permitted under specific circumstances.
  • 46.116(h) - A copy of the template consent form must be posted on a federal website after the clinical trial (sponsored by a federal department or agency) is closed to recruitment and no later than 60 days after the last study visit by any subject. DHHS guidance is forthcoming.
Documentation of Informed Consent
45 CFR 46.117
  • 46.117(a) - Includes electronic format.
  • 46.117(b) - Ensures that Key Information was presented first to the subject.
  • 46.117(c) - New criteria for a waiver of documentation (signed) of informed consent.

When was Initial IRB Approval Issued for the Research?
Prior to January 21, 2019 On or after January 21, 2019
Review Type Exempt Researchers do not need to take any action. At time of the protocol’s next amendment, the exempt form will automatically update to the new regulations. All new exempt protocols will adhere to the 2018 requirements, regardless of funding.
Non-Exempt Federally funded research will need to transition to the 2018 requirements at time of next renewal. Non-federally funded research will not be required to transition. Federally funded research must follow the 2018 requirements. Non-federally funded research is encouraged to follow the 2018 requirements.